MedFact Engineering GmbH is a company fully certified according to EN ISO 13485 since 2009 and since 2015 FDA listed and audited.
MedFact Engineering GmbH works with the latest technologies, but also with proven, precise engineering techniques. The technical equipment corresponds to the state of the art, such as the class 10,000 cleanroom (US Federal Standard 209b). With a number of 28 employees, including 6 employees in R&D and RA MedFact has a broad experience and resources in all phases from product development to post market surveillance.
The services offered include development, OEM production, packaging and sterilization, approval and distribution.
Various services in connection with the preparation of licensing-relevant technical files and their specific content as well as development projects in the fields of cardiology, electrophysiology, neurology and gastroenterology have been implemented on an international level in recent years.